BMS and Sanofi recall 64 million Avalide tablets

pharmafile | January 18, 2011 | News story | Manufacturing and Production Avalide, Avapro, Bristol-Myers Squibb, GMP, Good Manufacturing Practice, Sanofi-Aventis, hypertension, irbesartan 

Bristol-Myers Squibb and Sanofi-Aventis have started another massive recall of their antihypertensive product Avalide because a manufacturing defect could affect its activity.

This is the second time in recent months that Avalide (irbesartan HCl and hydrochlorothiazide) has had to be pulled back from the marketplace, with BMS and Sanofi recalling product distributed in the US, Canada, Mexico, Puerto Rico and Argentina.

Last September, the two companies were forced to recall more than two million packs of Avalide – equivalent to around 60 million tablets – in the US, Canada, Mexico, Argentina and Australia. Other brand names for the combination involved in that recall were Coaprovel, Karvezide and Avapro HCT.

The same manufacturing defect is thought to be responsible for both recalls. According to the FDA, the problem with the offending Avalide batches is a deviation in Good Manufacturing Practice which could affect the crystal structure of the active ingredients.

Specifically, the batches had been subjected to longer granulation than normal during production which caused higher-than-usual levels of a secondary crystal form of irbesartan.  This second crystal form has lower solubility than then intended form, which could affect its ability to be absorbed into the body.

Since September, BMS has developed a more sensitive test to confirm the presence of the less-soluble crystal form of irbesartan, and that prompted the latest recall, according to a Reuters report.

The first recalled batches were made at a facility operated by Bristol-Myers Squibb Manufacturing in Humacao, Puerto Rico. Some of the latest batches were manufactured at that plant, while others were made at BMS’ facility in Evansville, Indiana.

BMS said there was no evidence of any patient harm or reduced effectiveness with the recalled product. Combined sales of Avalide and Avapro (irbesartan monotherapy) were $924 million in the first nine months of 2010.

Phil Taylor

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